Esophageal CancerPhase 2NCT00985192
Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer
A Phase 2 study testing everolimus and laboratory biomarker analysis in people with Esophageal Cancer and Gastric Cancer, run by Translational Oncology Research International at 18 sites in United States.
Trial summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- everolimus and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 2009to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of adenocarcinoma of the upper gastrointestinal tract
- Metastatic or unresectable disease
- Received 1-2 prior chemotherapy or biological therapy regimens for unresectable or metastatic disease
- Measurable disease in ≥ 1 dimension by CT scan or MRI
- Patients whose only measurable lesion is a metastatic lymph node are eligible provided they have permission from the principal investigator
- ECOG performance status 0-1
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- Life expectancy > 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if there is liver metastasis)
- Creatinine clearance > 60 mL/min
- Fasting serum cholesterol < 300 mg/dL or < 7.75 mmol/L*
- Fasting triglycerides < 2.5 times ULN*
- INR ≤ 3.5 (for patients on warfarin)
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 4 months after completion of study treatment (oral, implantable, or injectable contraceptives are not considered effective contraception for this study)
- More than 30 days since prior chemotherapy, surgery, radiotherapy, or investigational agents
Who cannot join
- uncontrolled diabetes mellitus, defined as fasting serum glucose > 1.5 times ULN
- severely impaired lung function
- known HV infection
- active, bleeding diathesis
- unstable angina pectoris, symptomatic congestive heart failure, or myocardial infarction within the past 6 months
- serious uncontrolled cardiac arrhythmia
Show all 18Show fewer
- active or uncontrolled infection requiring parenteral antimicrobials
- known liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
- inability to swallow, impaired gastrointestinal (GI) function, or GI disease (e.g., ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that would significantly alter the absorption of study drugs or preclude the use of oral medications
- other malignancy within the past 5 years except for nonmelanoma skin cancer or cervical carcinoma in situ
- known hypersensitivity to everolimus, sirolimus, or temsirolimus or to their excipients
- other medical conditions that, in the opinion of the investigator, would preclude study participation
- prior mTOR inhibitors (e.g., rapamycin, CCI-779)
- concurrent chronic treatment with steroids or another immunosuppressive agent
- concurrent prophylactic use of hematopoietic growth factors
- concurrent anticancer agents or therapy (including radiotherapy)
- other concurrent experimental agents
- concurrent strong inhibitors or inducers of the isoenzyme CYP3A4
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Antelope Valley Cancer Center
Lancaster, California, 93534
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Suburban Hematology-Oncology Associates, P.A.
Lawrenceville, Georgia, 30045
Pacific Shores Medical Group
Long Beach, California, 90813
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Translational Oncology Research International (TORI) Network
Los Angeles, California, 90095
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)
Redondo Beach, California, 90277
Sansum Medical Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Trivalley Oncology Hematology
Westlake Village, California, 91361
About this study
Official title: A Phase II Study of the mTOR Inhibitor RAD001 in Previously Treated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Stomach
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the overall disease-control rate (complete response, partial response, or stable disease) in patients with previously treated unresectable or metastatic adenocarcinoma of the upper gastrointestinal tract treated with everolimus.
Secondary
- To determine the safety and toxicity of everolimus in these patients.
- To determine the efficacy of everolimus, in terms of time to response, duration of response, time to tumor progression, progression-free survival, and overall survival, in these patients.
- To explore potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in blood and tumor biopsy samples from these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Blood, serum, and tumor tissue samples are collected for biomarker analysis.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- everolimus, laboratory biomarker analysis
- Keywords
- adenocarcinoma of the esophagus, adenocarcinoma of the stomach, recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Receives: Drug: everolimus; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Measured: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.
Secondary outcomes (5)
Overall Survival
Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan-Meier method.
Measured: 2.5 year
Efficacy in Terms of Progression Free Response
Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan-Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.
Measured: evry 3 months in year 1, every 6 months after that
Observed Biomarkers
Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.
Measured: 30 months
Biomarker Correlations: Progression Free Survival
Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
Measured: 30 months
Biomarker Correlations: Time to Progression
Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zev A. Wainberg, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985192
- Sponsor's protocol ID
- CDR0000655574
- Other IDs
- UCLA-TRIO-TORI-GI-06, IRB# 09-07-061-01, NOVARTIS-UCLA-TRIO-TORI-GI-06
- Status last verified
- Feb 2016
- First submitted
- 25 Sep 2009
- Last updated
- 5 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the mTOR Inhibitor RAD001 in Previously Treated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Stomach
- ClinicalTrials.gov ID
- NCT00985192
- Acronym / sponsor ID
- CDR0000655574
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- adenocarcinoma of the esophagus, adenocarcinoma of the stomach, recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Los Angeles
- Study start
- Sep 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 29 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the overall disease-control rate (complete response, partial response, or stable disease) in patients with previously treated unresectable or metastatic adenocarcinoma of the upper gastrointestinal tract treated with everolimus.
Secondary
- To determine the safety and toxicity of everolimus in these patients.
- To determine the efficacy of everolimus, in terms of time to response, duration of response, time to tumor progression, progression-free survival, and overall survival, in these patients.
- To explore potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in blood and tumor biopsy samples from these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Blood, serum, and tumor tissue samples are collected for biomarker analysis.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: everolimus, Other: laboratory biomarker analysisPatients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of adenocarcinoma of the upper gastrointestinal tract
- Metastatic or unresectable disease
- Received 1-2 prior chemotherapy or biological therapy regimens for unresectable or metastatic disease
- Measurable disease in ≥ 1 dimension by CT scan or MRI
- Patients whose only measurable lesion is a metastatic lymph node are eligible provided they have permission from the principal investigator
Key exclusion criteria (18 listed)
- uncontrolled diabetes mellitus, defined as fasting serum glucose > 1.5 times ULN
- severely impaired lung function
- known HV infection
- active, bleeding diathesis
- unstable angina pectoris, symptomatic congestive heart failure, or myocardial infarction within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimus | Drug | Everolimus |
| laboratory biomarker analysis | Other | Everolimus |
Primary outcome
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
Time frame: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.
Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
5 secondary outcomes
Overall Survival
Time frame: 2.5 year
Efficacy in Terms of Progression Free Response
Time frame: evry 3 months in year 1, every 6 months after that
Observed Biomarkers
Time frame: 30 months
Biomarker Correlations: Progression Free Survival
Time frame: 30 months
Biomarker Correlations: Time to Progression
Time frame: 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev A. Wainberg, MD principal investigator
Jonsson Comprehensive Cancer Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus and laboratory biomarker analysis in people with Esophageal Cancer and Gastric Cancer, run by Translational Oncology Research International at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus. (time frame: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.